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Extranodal Marginal Zone Lymphoma of Mucosa-Associated Lymphoid TissuePhase 2NCT00711828

Rituximab, Cyclophosphamide, Bortezomib, and Dexamethasone in Treating Patients With Relapsed or Refractory Low-Grade Follicular Lymphoma, Waldenstrom Macroglobulinemia, or Mantle Cell Lymphoma

A Phase 2 study testing Bortezomib, Rituximab and Cyclophosphamide in people with Extranodal Marginal Zone Lymphoma of Mucosa-Associated Lymphoid Tissue and Nodal Marginal Zone Lymphoma, run by Mayo Clinic at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This phase II trial is studying how well giving rituximab and cyclophosphamide together with bortezomib and dexamethasone (R-CyBor-D) works in treating patients with relapsed or refractory low-grade follicular lymphoma, Waldenstrom macroglobulinemia, or mantle cell lymphoma. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Bortezomib, Rituximab and Cyclophosphamide
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
21 participants
Where
2 sitesUnited States
Study dates
Aug 2008to 6 Apr 2018
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histological confirmation of relapsed or refractory follicular Grades 1 or 2 lymphoma, mantle cell lymphoma (MCL), small lymphocytic lymphoma/chronic lymphocytic leukemia (SLL/CLL), extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue (MALT) type, nodal marginal zone B-cell lymphoma, splenic marginal zone B-cell lymphoma, or lymphoplasmacytic lymphoma (Waldenstrom's macroglobulinemia/WM) by biopsy ≤ 6 months prior to registration
  • NOTE: MCL diagnosis should be confirmed by cyclin D1 staining or fluorescence in situ hybridization (FISH) (t(11;14))
  • Measurable disease by computed tomography (CT), positron emission tomography (PET)/CT or magnetic resonance imaging (MRI) scans with lymph nodes ≥2.0 cm in at least one dimension or tumor cells in the blood ≥ 5 x10^9/L
  • NOTE: Lymphoplasmacytic lymphoma (WM) patients without lymphadenopathy must have 1.) >10% lymphocytes, lymphoplasmacytic cells or plasma cells on a bone marrow aspirate/biopsy, and 2.) quantitative IgM ≥ 400mg/dL
  • Expected survival > 3 months
  • ECOG Performance Status (PS) 0, 1 or 2
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  • Absolute Neutrophil Count ≥ 1200
  • Platelet ≥ 75000
  • Hemoglobin ≥ 8.0 g/dL
  • Total bilirubin ≤ 1.5 x upper limit of normal (ULN)
  • Alkaline phosphatase ≤ 3 x ULN
  • Aspartate aminotransferase (AST) ≤ 3 x ULN
  • Creatinine ≤ 1.5 x ULN
  • Female subject is either postmenopausal for at least 1 year before the screening visit, is surgically sterilized or if they are of childbearing potential, agree to practice 2 effective methods of contraception from the time of signing the informed consent form through 30 days after the last dose of VELCADE (bortezomib), or agree to completely abstain from heterosexual intercourse
  • Male subjects, even if surgically sterilized (i.e., status postvasectomy) must agree to 1 of the following: practice effective barrier contraception during the entire study treatment period and through a minimum of 30 days after the last dose of study drug, or completely abstain from heterosexual intercourse
  • Voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care
  • Willingness to return to Mayo Clinic institution for follow-up
  • Negative serum pregnancy test done <7 days prior to registration, for women of childbearing potential only
  • Willingness to complete questionnaires by themselves or with assistance

Who cannot join

  • Any of the following because this study involves an investigational agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown:
  • Pregnant women -- confirmation that the subject is not pregnant must be established by a negative serum B-human chorionic gonadotropin (B-hCG) pregnancy test result obtained during screening. Pregnancy testing is not required for post-menopausal or surgically sterilized women;
  • Nursing women;
  • Men or women of childbearing potential who are unwilling to employ adequate contraception
  • Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and adverse event of the prescribed regimen
  • Patients known to be human immunodeficiency virus (HIV) positive
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  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
  • Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm
  • Diagnosed or treated for another malignancy ≤ 3 years prior to registration, with the exception of complete resection of basal cell carcinoma or squamous cell carcinoma of the skin, an in situ malignancy or low-risk prostate cancer after curative therapy
  • NOTE: If there is a history of prior malignancy, they must not be receiving other specific treatment (other than hormonal therapy) for their cancer
  • Patient has received other investigational drugs ≤ 14 days prior to registration
  • Patient has hypersensitivity to bortezomib, boron or mannitol
  • Myocardial infarction ≤ 6 months prior to registration or has New York Heart Association (NYHA) Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities
  • NOTE: Prior to study entry, any electrocardiogram (ECG) abnormality at Screening has to be documented by the investigator as not medically relevant
  • Previous cancer therapy, hormonal therapy and surgery < 4 weeks prior to registration
  • Patient has ≥ Grade 2 peripheral neuropathy
  • Radiation therapy within 3 weeks before randomization
  • Enrollment of subjects who require concurrent radiotherapy (which must be localized in its field size) should be deferred until the radiotherapy is completed and 3 weeks have elapsed since the last date of therapy

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • Mayo Clinic in Arizona

    Scottsdale, Arizona, 85259

Other trials in United States

About this study

Official title: A Phase 2 Clinical Trial of Rituximab, Cyclophosphamide, Bortezomib (VELCADE), and Dexamethasone (R-CYBOR-D) in Relapsed Low Grade and Mantle Cell Lymphoma

This phase II trial is studying how well giving rituximab and cyclophosphamide together with bortezomib and dexamethasone (R-CyBor-D) works in treating patients with relapsed or refractory low-grade follicular lymphoma, Waldenstrom macroglobulinemia, or mantle cell lymphoma. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as cyclophosphamide and dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving rituximab and bortezomib together with combination chemotherapy may kill more cancer cells.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To assess tumor response to R-CyBor-D in patients with relapsed follicular (Gr 1 or 2), mantle cell, marginal zone lymphomas, small lymphocytic lymphoma (SLL)/chronic lymphocytic leukemia (CLL) and lymphoplasmacytic (Waldenstrom's macroglobulinemia) lymphoma.

SECONDARY OBJECTIVES:

  1. To evaluate overall survival, progression-free survival, duration of response, and time to treatment failure of patients receiving R-CyBor-D.

II. To describe the adverse event profile (using National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE] v 3.0) of R-CyBor-D.

III. To evaluate quality of life for patient reported neurotoxicity using the Gynecologic Oncology Group's Functional Assessment of Cancer Therapy (FACT/GOG) neurotoxicity questionnaire, version 4.0.

OUTLINE:

Patients receive rituximab intravenously (IV) on day 1and cyclophosphamide orally (PO), bortezomib IV, and dexamethasone PO on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 3-6 months for up to 3 years.

Being tested
Bortezomib, Rituximab, Cyclophosphamide, Dexamethasone, Questionnaire Administration
Medical subject headings
Lymphoma, B-Cell, Marginal Zone, Lymphoma, Follicular, Lymphoma, Mantle-Cell, Leukemia, Lymphocytic, Chronic, B-Cell, Waldenstrom Macroglobulinemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BortezomibDrug

    Given IV

  • RituximabBiological

    Also called MOAB IDEC-C2B8

    Given IV

  • CyclophosphamideDrug

    Given PO

  • DexamethasoneDrug

    Also called DM

    Given PO

  • Questionnaire AdministrationOther

    Complete a quality of life questionnaire (FACT/GOG neurotoxicity questionnaire, version 4.0)

  • Quality-of-Life AssessmentOther

    Also called Quality of Life Assessment

    Complete a quality of life questionnaire (FACT/GOG neurotoxicity questionnaire, version 4.0)

Study groups in NCT00711828
Study groupRoleWhat they receive
Treatment (R-CYBOR-D)ExperimentalPatients receive rituximab IV on day 1and cyclophosphamide PO, bortezomib IV, and dexamethasone PO on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Receives: Drug: Bortezomib; Biological: Rituximab; Drug: Cyclophosphamide; Drug: Dexamethasone; Other: Questionnaire Administration; Other: Quality-of-Life Assessment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of Responses (Complete Response or Partial Response)

    A response is defined to be a Complete Response (CR) or Partial Response (PR) noted as the objective status on any evaluation (i.e., best response). The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients. A confidence interval for the true success proportion will be calculated according to the properties of the binomial distribution.

    Measured: up to 12 cycles

Secondary outcomes (5)

  1. Overall Survival

    Survival time is defined as the time from registration to death due to any cause. The distribution of survival time will be estimated using the method of Kaplan-Meier.

    Measured: Up to 3 years from registration

  2. Progression-free Survival

    Progression-free survival time is defined as the time from registration to the earliest date of documentation of disease progression or death, whichever occurs first. Progression is defines as having any new lesion or increase by 50% of previously involved sites from nadir. The distribution of progression-free survival time will be estimated using the method of Kaplan-Meier.

    Measured: Up to 3 years from registration

  3. Duration of Response

    Duration of response is defined for all evaluable patients who have achieved an objective response as the date at which the patient's earliest objective status is first noted to be either a CR or PR to the earliest date progression is documented. MR for Waldenstrom lymphoma will not be included as a response. Median duration of response and the confidence interval for the median duration will be computed.

    Measured: Up to 3 years from registration

  4. Time to Treatment Failure

    Time to treatment failure is defined to be the time from registration to the date at which the patient is removed from treatment due to progression, adverse events, or refusal. If the patient is considered to be a major treatment violation or is taken off study as a non-protocol failure, the patient will be censored on the date they are removed from treatment. The distribution of time to treatment failure will be estimated using the method of Kaplan-Meier.

    Measured: Up to 3 years from registration

  5. Adverse Events

    Adverse events were assessed according to the NCI Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0 after each cycle of treatment. The maximum grade for each type of adverse event were recorded for each patient, and frequency tables were reviewed to determine patterns. For this endpoint, the number of patients receiving a Grade 3, Grade 4, or Grade 5 as their highest reported grade regardless of attribution are reported. A full list of adverse events are reported in the Adverse Events section of this report.

    Measured: up to 12 cycles (28 days per cycle) of treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jul 2008 (estimated)
  2. Study startAug 2008
  3. Primary completionNov 2013
  4. Study completion6 Apr 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
21 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00711828
Sponsor's protocol ID
MC0883
Other IDs
NCI-2011-02991, MC0883, P30CA015083
Status last verified
Apr 2019
First submitted
8 Jul 2008
Last updated
16 Apr 2019
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Bortezomib, Rituximab and Cyclophosphamide in people with Extranodal Marginal Zone Lymphoma of Mucosa-Associated Lymphoid Tissue and Nodal Marginal Zone Lymphoma, run by Mayo Clinic at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 19 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Jan 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of Responses (Complete Response or Partial Response) (time frame: up to 12 cycles). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00711828.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2019; AzTrials last refreshed its copy on 26 Oct 2026.

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